Health Action International’s (HAI) 2019 European workplan builds on previous successes supported by CHAFEA. It provides a response to persistent shortcomings in European medicines policy and regulation. HAI’s workplan is aligned with the objectives of the Third Health Programme and with HAI’s organisational goals: (1) Access to Affordable Medicines, (2) Medicines Safety, Added Therapeutic Value and Responsible Use, (3) Democratisation of Medicines Policy. In 2019, HAI will continue to address factors affecting access to medicines, including Intellectual Property Rights (IPR) while campaigning to broaden public and policy support in the European Union for alternative models of biomedical innovation that prioritise unmet medical needs, contribute to medicines affordability and ensure public return on public investment. Through the ‘Our Medicines, Our Right’ Campaign, we will seek to broaden policy support to medicines price transparency and R&D costs, as well as needs driven R&D modelling. We will roll-out campaign activities in Germany and thereby build bridges between policy discussions at the EU and Member State level. HAI will, furthermore, implement initiatives to promote responsible use of medicines, including antibiotics, by healthcare professionals. As a member of the Health Technology Assessment (HTA) Network Stakeholders Pool, HAI will contribute to the work programme of the network and advocate for strengthened EU collaboration on HTA. We will advocate specifically for joint HTA to be driven by high evaluation standards, transparency and independence from commercial interests. HAI will also seek policy and regulatory support for a more robust EU framework for medicines market authorization, in particular for cancer medicines. As a member of the European Medicines Agency (EMA) Patients’ and Consumers’ Working Party (PCWP), HAI will bring an independent consumers’ voice to EMA’s discussions and public consultations.
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Health Action International’s work in Europe focuses on improving access to medicines through evidence-based advocacy, sharing expertise and engaging for change. To do this we campaign for greater transparency, and rationally used, affordable, safe and effective medicines.

PRIORITIES FOR 2021
European Parliament Working Group on Innovation, Access to Medicines and Poverty-related Diseases: HAI and MSF provide the secretariat for a group of European Parliamentarians interested in access to medicines issues. Over 2021 we will mobile this group to advocate on numerous issues.

Furthermore, we aim to change the narrative around TRIPS flexibilities to encourage more regular use of these legitimate tools. In 2021, we will implement the conclusions of the Great Health Hack, including producing the beta version of the technical solution suggested by participants. We hope to broaden understanding of the evidence base behind IP flexibilities and facilitate more policymakers to support implementation of a sustainable pricing system.

We will continue to share our recommendations how Member States can achieve greater transparency in medicines prices, research and development (R&D) costs and reimbursement decisions.

We will facilitate medical students and healthcare professionals to detect, counter and avoid exposure to pharmaceutical promotion.

As always, there will be many other upcoming issues and opportunities in access to medicines this year, both regionally and globally. We will be watching how other dossiers and events unfold in the fight against medicine shortages, also in light of COVID-19.

We pride ourselves on being active members of European civil society and part of the global access to medicines movement, via groups like the European Alliance for Responsible R&D and Affordable Medicines, Medicijnen Netwerk Nederland, HTA Network Stakeholder Pool and the EMA PCWP.

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The ERN ReCONNET 3-year Work Plan will set the stage for crucial achievements in the field of rare ad complex connective tissue diseases (rCTDs), allowing the Network to address its main commitment: the benefit of patients affected by rCTDs.
As the aim of the 3-year program is to establish, coordinate and manage patients and HCPs communities and to pool knowledge and expertise across the EU, all the target groups will participate in all the activities planned. Specifically, the main target groups are represented by: patients, caregivers and families, HCP members, healthcare professionals, scientific societies.
The main activities that will be carried out are related to the coordination and management, empowerment and engagement of patients, families and caregivers, sharing of best practice, training and e-learning, research and innovation knowledge, dissemination and networking and sustainability.
The expected results of the activities of the next three years will be represented by the availability of specific tools aimed at harmonizing the clinical and economical approach to rCTDs and at creating minimum standards of healthcare services essential for the management of rCTDs across Europe and providing a crucial impact on the lives of more than 500.000 people affected by rCTDs.

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The general objective for EUnetHTA JA3 is to increase the use, quality and efficiency of joint HTA work at European level to support evidence-based, sustainable and equitable choices in healthcare and health technologies and ensure re-use in regional and national HTA reports and activities, in order notably to avoid duplication of assessments. An overarching objective is to develop a general strategy, principles and proposal for a scientific and technical mechanism of permanent sustainable European Collaboration on HTA in the light of the Directive on CBHC. During the JA3 the collaborative production of structured HTA core information, including rapid HTAs will be structurally implemented and the methodologies and production related information and communication technology infrastructure will be finalised as to stand alone from 2020 onwards. EUnetHTA JA3 will also aim to increase the alignment between HTA reports used for reimbursement decisions and clinical practice guidelines that are used by physicians in daily practice. Additionally, EUnetHTA JA3 will also support more alignment of different processes in the lifecycle of health technologies. For instance, processes on market authorization and HTA of pharmaceuticals could be organised in a more closely aligned fashion which may lead to a timelier and more efficient process promoting earlier patient access to products that have a real added value. EUnetHTA JA3 will also contribute to the discussion on the assessment of the effectiveness and safety of new medical devices as is currently taken place as part of the debate on new European legislation for medical devices. Finally, all these outcomes will contribute to the dissemination of health information and knowledge, thus improving policy-and decision-making in the health systems, which turns into protection of citizens against unsafe or ineffective technologies and improves access to high value health technologies. Ultimately this contributes to imTo be developed
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